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FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia
April 17, 2018 -- The U.S. Food and Drug Administration today approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 17, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Afinitor Disperz (everolimus) for Tuberous Sclerosis Complex-Associated Partial-Onset Seizures
April 11, 2018 -- On April 10, 2018, the Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 12, 2018 Category: Drugs & Pharmacology Source Type: news

Pacira Announces FDA Approval of Exparel as a Nerve Block to Produce Regional Analgesia
PARSIPPANY, N.J., April 06, 2018 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) to broaden the use of Exparel... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 6, 2018 Category: Drugs & Pharmacology Source Type: news

Rubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer
BOULDER, Colo.--(BUSINESS WIRE)--Apr. 6, 2018-- Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that the U.S. Food and Drug Administration (FDA) has approved Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Bydureon (exenatide extended-release) for Use with Basal Insulin in Patients with Type 2 Diabetes with Inadequate Glycemic Control
April 3, 2018 AstraZeneca today announced the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes (T2D) with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 3, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Expands Approval of Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
March 29, 2018 -- The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 29, 2018 Category: Drugs & Pharmacology Source Type: news

Mylan Introduces Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Triple Combo Once-Daily HIV Treatment in the U.S.
HERTFORDSHIRE, England and PITTSBURGH, March 28, 2018 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Toujeo (insulin glargine) Max SoloStar
BRIDGEWATER, N.J., March 27, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Sanofi's Toujeo (insulin glargine 300 Units/mL) Max SoloStar, the highest capacity long-acting insulin pen that will be available on the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 27, 2018 Category: Drugs & Pharmacology Source Type: news

Novartis Drug Tasigna Approved by FDA to Treat Children with Rare Form of Leukemia
Basel, March 22, 2018 - Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ilumya (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis
MUMBAI, India and PRINCETON, N.J., March 21, 2018 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ilumya (tildrakizumab-asmn) for the treatment of adults with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Lucentis (ranibizumab injection) 0.3 mg Prefilled Syringe for Diabetic Macular Edema and Diabetic Retinopathy
South San Francisco, CA -- March 21, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis (ranibizumab injection) 0.3 mg prefilled syringe... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Expands Approval of Adcetris (brentuximab vedotin) for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination with Chemotherapy
March 20, 2018 -- The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 20, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
KING OF PRUSSIA, Pa. – March 16, 2018 – Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) approved Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) as the first and only... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Trogarzo (ibalizumab-uiyk) for Treatment-Experienced Patients with Multidrug Resistant HIV
March 6, 2018 -- Today, the U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Latuda (lurasidone HCl) for Bipolar Depression in Pediatric Patients (10 to 17 Years of Age)
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- March 6, 2018 -- Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) that expands the use of Latuda... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

Bristol-Myers Squibb ’s Opdivo (nivolumab) Now the First and Only FDA-Approved PD-1 Inhibitor to Offer Every Four-Week Dosing
PRINCETON, N.J.--(BUSINESS WIRE) March 6, 2018 --Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo (nivolumab)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

Mylan to Introduce Cimduo (lamivudine and tenofovir disoproxil fumarate) as a New Cost-Saving HIV Combination Treatment in the U.S.
HERTFORDSHIRE, England and PITTSBURGH, March 2, 2018 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it will launch Cimduo, which was approved in February by the U.S. Food and Drug Administration (FDA).... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Mylan to Introduce Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) as a New Cost-Saving HIV Combination Treatment in the U.S.
HERTFORDSHIRE, England and PITTSBURGH, March 2, 2018 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it will launch a new HIV treatment, Symfi Lo, which was approved in February by the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Otonomy Announces FDA Approval of Otiprio (ciprofloxacin otic suspension) for Acute Otitis Externa
SAN DIEGO, March 02, 2018 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for otology, today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Sorrento Therapeutics Subsidiary, Scilex, Receives FDA Approval for Non-Opioid ZTlido (lidocaine topical system) 1.8% for Post-Herpetic Neuralgia Pain
SAN DIEGO, Feb. 28, 2018 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ:SRNE) ( “Sorrento”), and its majority-owned subsidiary, Scilex Pharmaceuticals Inc. (“Scilex”), received approval from the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 28, 2018 Category: Drugs & Pharmacology Source Type: news

Lilly Receives Additional FDA Approval for Verzenio (abemaciclib), as Initial Treatment for Advanced Breast Cancer
INDIANAPOLIS, Feb. 26, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved Verzenio (abemaciclib) in combination with an aromatase inhibitor (AI) as initial... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain
CORALVILLE, Iowa, Feb. 23, 2018 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 23, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Use of Luzu (luliconazole) Cream in Pediatric Patients with Athlete ’s Foot, Jock Itch and Ringworm
RALEIGH, N.C., FEBRUARY 22, 2018 – Ortho Dermatologics, a division of Valeant Pharmaceuticals North America, LLC (NYSE: VRX and TSX: VRX) (“Valeant”), today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 22, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Osmolex ER (amantadine) for the treatment of Parkinson ’s Disease and Drug-Induced Extrapyramidal Reactions
BRIDGEWATER, N.J., Feb. 19, 2018 (GLOBE NEWSWIRE) -- Osmotica Pharmaceutical US LLC ( “Osmotica” or the “Company”), a privately-held specialty pharmaceutical company developing novel central nervous system (CNS) treatments utilizing its... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 19, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Imfinzi (durvalumab) for Unresectable Stage III Non-Small Cell Lung Cancer
February 16, 2018 -- The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Expands Approval of Imfinzi (durvalumab) to Reduce the Risk of Non-Small Cell Lung Cancer Progressing
February 16, 2018 -- The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Erleada (apalutamide) for Non-Metastatic Castration-Resistant Prostate Cancer
February 14, 2018 -- The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 14, 2018 Category: Drugs & Pharmacology Source Type: news

AMAG Pharmaceuticals Announces FDA Approval of Makena (hydroxyprogesterone caproate injection) Subcutaneous Auto-Injector to Reduce the Risk of Preterm Birth in Certain At-Risk Women
WALTHAM, Mass., Feb. 14, 2018 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) approved the Makena subcutaneous auto-injector drug-device combination product as a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 14, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene
BOSTON--(BUSINESS WIRE) Feb 12, 2018 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved Symdeko (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 12, 2018 Category: Drugs & Pharmacology Source Type: news

Icon Bioscience Receives FDA Approval for Dexycu (dexamethasone intraocular suspension) for Treating Inflammation Associated With Cataract Surgery
Newark, CA (February 12, 2018) – Icon Bioscience, Inc. (IBI), a specialty biopharmaceutical company focused on utilizing its Verisome® drug-delivery platform to develop unique intraocular eye-care therapeutics, today announced that the United... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 12, 2018 Category: Drugs & Pharmacology Source Type: news

Zytiga (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer
HORSHAM, PA, Feburary 8, 2018 – The Janssen Pharmaceutical Companies of Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Zytiga (abiraterone acetate) in combination with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 8, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for Treatment of HIV-1 Infection
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 7, 2018-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 7, 2018 Category: Drugs & Pharmacology Source Type: news

AMAG Pharmaceuticals Announces FDA Approval of Feraheme (ferumoxytol injection) for All Eligible Adult Patients with Iron Deficiency Anemia
WALTHAM, Mass., Feb. 05, 2018 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its application to broaden the existing label for Feraheme (ferumoxytol injection) beyond the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 5, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Avycaz (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
DUBLIN, Feb. 1, 2018 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Allergan's supplemental New Drug Application (sNDA) to expand the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 1, 2018 Category: Drugs & Pharmacology Source Type: news

CutisPharma Announces FDA Approval of Firvanq (vancomycin) for Treatment of Clostridium Difficile Associated Diarrhea and Staphylococcus Aureus Colitis
WILMINGTON, Mass. (Jan. 29, 2018) – CutisPharma announced today that the US Food and Drug Administration (FDA) has approved Firvanq (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 29, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lutathera (lutetium Lu 177 dotatate) for Gastroenteropancreatic Neuroendocrine Tumors
January 26, 2018 -- The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 26, 2018 Category: Drugs & Pharmacology Source Type: news

Synergy Pharmaceuticals Announces FDA Approval of Trulance (plecanatide) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Adults
NEW YORK--(BUSINESS WIRE) January 25, 2018 -- Synergy Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Trulance (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 25, 2018 Category: Drugs & Pharmacology Source Type: news

Avion Pharmaceuticals Announces FDA Approval of Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) Oral Contraceptive
ATLANTA, Jan. 17, 2018 /PRNewswire/ -- Avion Pharmaceuticals, LLC, the makers of the Prenate ® line of prescription prenatal vitamins, received approval of its new drug application (NDA) for the oral contraceptive Balcoltra (levonorgestrel and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 17, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC
Ridgefield, Conn., January 16, 2018 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib) for the first-line treatment of patients... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer
January 12, 2018 -- The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 12, 2018 Category: Drugs & Pharmacology Source Type: news

GSK Receives FDA Approval for Expanded Indication for Fluarix Quadrivalent (Influenza Vaccine) for Persons 6 Months and Older
Philadelphia, PA, January 11, 2018 -- GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration ’s (FDA) Center for Biologics Evaluation and Research expanding the indication for Fluarix Quadrivalent... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 11, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma
THOUSAND OAKS, Calif., Jan. 5, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to expand the currently... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 5, 2018 Category: Drugs & Pharmacology Source Type: news

Bausch + Lomb Receives FDA Approval of Lumify (brimonidine tartrate) Over-the-Counter Eye Drop for the Treatment of Eye Redness
LAVAL, Quebec, Dec. 22, 2017 /PRNewswire/ -- Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ( " Valeant " ), today announced that the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Segluromet (ertugliflozin and metformin hydrochloride) for Type 2 Diabetes
KENILWORTH, N.J.& NEW YORK--(BUSINESS WIRE) December 22, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Steglujan (ertugliflozin and sitagliptin) for Type 2 Diabetes
KENILWORTH, N.J.& NEW YORK--(BUSINESS WIRE) December 22, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Steglatro (ertugliflozin) for Type 2 Diabetes
KENILWORTH, N.J.& NEW YORK--(BUSINESS WIRE) December 22, 2017 -- Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Updates the Label of Tasigna to Reflect that Certain Patients with a Type of Leukemia May be Eligible to Stop Treatment After Sustained Response
December 22, 2017 -- The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Giapreza (angiotensin II) to Treat Dangerously Low Blood Pressure
December 21, 2017 -- The U.S. Food and Drug Administration today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. " Shock, the inability to maintain... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2017 Category: Drugs & Pharmacology Source Type: news

Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency
CHARLESTON, S.C. December 20, 2017 -- Aeterna Zentaris Inc. (NASDAQ and TSX: AEZS), a specialty biopharmaceutical company engaged in developing and commercializing pharmaceutical therapies, announced today that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 20, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer
South San Francisco, CA -- December 20, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Perjeta ® (pertuzumab), in combination with Herceptin®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 20, 2017 Category: Drugs & Pharmacology Source Type: news